HPV-based Screening Among Women 23-29 Years of Age
Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
1 other identifier
interventional
180,000
1 country
2
Brief Summary
The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2020
CompletedFirst Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2038
March 19, 2025
March 1, 2025
18.1 years
November 30, 2021
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 1.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 2.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 3.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 4.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 5.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 6.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 7.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 8.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 9.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Measured once during 1 year, year 10.
Secondary Outcomes (10)
Cost-effectiveness of the new screening method
Measured once during 1 year, year 1.
Cost-effectiveness of the new screening method
Measured once during 1 year, year 2.
Cost-effectiveness of the new screening method
Measured once during 1 year, year 3.
Cost-effectiveness of the new screening method
Measured once during 1 year, year 4.
Cost-effectiveness of the new screening method
Measured once during 1 year, year 5.
- +5 more secondary outcomes
Study Arms (1)
HPV-based screening
EXPERIMENTALWomen 23-29 invited to cervical screening will have their samples analyzed for HPV.
Interventions
All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method.
Eligibility Criteria
You may qualify if:
- Women ages 23-29 invited to screening.
You may not qualify if:
- Women who do not show up for screening or do not consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Region of Skåne
Lund, Skåne County, 221 00, Sweden
Region Stockholm
Stockholm, 102 39, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joakim Dillner, MD, PhD
Karolinska University Hospital/Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Infectious Disease Epidemiology; Director of R&D
Study Record Dates
First Submitted
November 30, 2021
First Posted
February 8, 2022
Study Start
November 16, 2020
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2038
Last Updated
March 19, 2025
Record last verified: 2025-03